Goyal Shivani, Nunn Caitlin A, Rotondi Michael, Couperthwaite Amy B, Reiser Sally, Simone Angelo, Katzman Debra K, Cafazzo Joseph A, Palmert Mark R
Centre for Global eHealth Innovation, Techna Institute, University Health Network, Toronto, ON, Canada.
Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, ON, Canada.
JMIR Mhealth Uhealth. 2017 Jun 19;5(6):e82. doi: 10.2196/mhealth.7336.
While optimal blood glucose control is known to reduce the long-term complications associated with type 1 diabetes mellitus, adolescents often struggle to achieve their blood glucose targets. However, their strong propensity toward technology presents a unique opportunity for the delivery of novel self-management interventions. To support type 1 diabetes self-management in this population, we developed the diabetes self-management app bant, which included wireless blood glucose reading transfer, out-of-range blood glucose trend alerts, coaching around out-of-range trend causes and fixes, and a point-based incentive system.
The primary objective was to evaluate bant 's effect on hemoglobin A (HbA) through a randomized controlled trial (RCT). Secondary measures (eg, self-monitoring of blood glucose [SMBG]) were also collected to assess bant 's impact on the self-management behaviors of adolescents with type 1 diabetes.
We enrolled 92 adolescents into a 12-month RCT, with 46 receiving usual care and 46 receiving usual care plus bant. Clinical outcome data were collected at quarterly research visits via validated tools, electronic chart review, glucometer downloads, and semistructured interviews. App satisfaction was assessed at 6 and 12 months, and at trial end, users ranked bant components based on perceived usefulness. Mobile analytics captured frequency of blood glucose uploads, which were used to categorize participants into high, moderate, low, or very low engagement levels.
Linear mixed models showed no changes in primary and secondary clinical outcomes. However, exploratory regression analysis demonstrated a statistically significant association between increased SMBG and improved HbA in the intervention group. For a subgroup of bant users taking SMBG ≥5 daily, there was a significant improvement in HbA of 0.58% (P=.02), while the parallel subgroup in the control arm experienced no significant change in HbA (decrease of 0.06%, P=.84). Although app usage did diminish over the trial, on average, 35% (16/46 participants) were classified as moderately or highly engaged (uploaded SMBG ≥3 days a week) over the 12 months.
Although primary analysis of clinical outcomes did not demonstrate differences between the bant and control groups, exploratory analysis suggested that bant may positively impact the use of SMBG data and glycemic control among youth. The next generation of bant will aim to remove barriers to use, such as deploying the app directly to personal devices instead of secondary research phones, and to explore the utility of integrating bant into routine clinical care to facilitate more frequent feedback. Future evaluations of mHealth apps should consider more robust research tools (eg, ResearchKit) and alternative RCT study designs to enable more rapid and iterative evaluations, better suited to the nature of rapidly evolving consumer technology.
ClinicalTrials.gov NCT01899274; https://clinicaltrials.gov/ct2/show/NCT01899274 (Archived by WebCite at http://www.webcitation.org/6qWrqF1yw).
虽然已知最佳血糖控制可减少与1型糖尿病相关的长期并发症，但青少年往往难以实现其血糖目标。然而，他们对技术的强烈倾向为提供新颖的自我管理干预措施带来了独特机会。为了支持该人群的1型糖尿病自我管理，我们开发了糖尿病自我管理应用程序bant，其功能包括无线血糖读数传输、血糖超出范围趋势警报、针对超出范围趋势原因及解决方法的指导，以及基于积分的激励系统。
主要目的是通过随机对照试验（RCT）评估bant对糖化血红蛋白（HbA）的影响。还收集了次要指标（如血糖自我监测[SMBG]），以评估bant对1型糖尿病青少年自我管理行为的影响。
我们招募了92名青少年参加为期12个月的RCT，其中46人接受常规护理，46人接受常规护理加bant。临床结局数据在每季度的研究访视时通过经过验证的工具、电子病历审查、血糖仪数据下载和半结构化访谈收集。在6个月和12个月时评估应用程序满意度，在试验结束时，用户根据感知有用性对bant的组件进行排名。移动分析记录了血糖上传频率，用于将参与者分为高、中、低或极低参与度水平。
线性混合模型显示主要和次要临床结局均无变化。然而，探索性回归分析表明，干预组中SMBG增加与HbA改善之间存在统计学上的显著关联。对于每天进行SMBG≥5次的bant用户亚组，HbA有显著改善，提高了0.58%（P = 0.02），而对照组的平行亚组HbA无显著变化（下降0.06%，P = 0.84）。尽管在试验过程中应用程序的使用确实减少，但平均而言，在12个月内35%（16/46名参与者）被归类为中度或高度参与（每周上传SMBG≥3天）。
虽然对临床结局的初步分析未显示bant组与对照组之间存在差异，但探索性分析表明，bant可能对青少年使用SMBG数据和血糖控制产生积极影响。下一代bant将旨在消除使用障碍，例如直接将应用程序部署到个人设备而不是用于二次研究的手机上，并探索将bant整合到常规临床护理中的效用，以促进更频繁的反馈。未来对移动健康应用程序的评估应考虑更强大的研究工具（如ResearchKit）和替代的RCT研究设计，以实现更快速和迭代的评估，更适合快速发展的消费技术的性质。
ClinicalTrials.gov NCT01899274；https://clinicaltrials.gov/ct2/show/NCT01899274（由WebCite存档于http://www.webcitation.org/6qWrqF1yw）
